A UK CENTRE OF EXCELLENCE FOR THE BIOSCIENCE INDUSTRY TRAINING

YARM ROAD

B6275

DARLINGTON TOWN CENTRE

HAUGHTON ROAD

A68 A167

A1(M)

A66

A66(M)

A1150

INTRODUCTION TO DOWNSTREAM BIOPROCESSING

CAG

1203

2

National Horizons CentreDarlingtonDL1 1HG

T: 01642 738777E: info@nationalhorizonscentre.org.uk

A66

DELIVERED IN PARTNERSHIP WITH CYTIVA

VIRAL VECTORS MANUFACTURING02 TRAINING 03

WELCOME

As a National Training Centre for Advanced Therapies, funded from the Department for Business, Energy & Industrial Strategy (BEIS) and Innovate UK (IUK) delivered through the Cell and Gene Therapy Catapult, our courses are industry approved and we have worked closely with key bioindustry leaders across the sector to ensure our courses have been designed to deliver vital skills needed for advanced therapies, vaccines manufacturing and bioprocessing.

Welcome to the National Horizons Centre (NHC). We are Teesside University’s centre of excellence for the biosciences and healthcare sector. With research, partnerships and training at our core, we bring together industry, academia, talent and world-class facilities to create real-world impact.

Dr Jen VanderhovenDIRECTOR

The NHC is one of the National Training Centres part of the ATSTN programme funded from the Department for Business, Energy & Industrial Strategy (BEIS) and Innovate UK (IUK) delivered through the Cell and Gene Therapy Catapult.

The course introduces delegates to chromatography and downstream processes and the principles of purification and membrane separations.

Our unique training facility houses state-of-the-art equipment that provides delegates with the opportunity to gain hands-on practical training in complex bioprocessing procedures, including the Cytiva AKTA platform and UNICORN software.

I look forward to welcoming you to the NHC.

DAY 2: Chromatography- biologics purification and membrane separationsLecture four Membrane materials, properties and devicesDiscussion of typical materials used for biopharmaceutical filtration processes, their properties, and the configuration of different filter devices

Lecture five Introduction to normal flow and crossflow filtrationIntroduction to the scientific principles of normal flow and crossflow filtration used in biopharmaceutical production

Lecture six Operation of a normal flow filtration processDeeper dive into setting up and running a normal flow filtration process

Lab four Chromatography> AKTA Purification> Program an IMAC method> Prepare the system> Purify a His-tagged protein> Analyse the chromatogram

Lab five ImagingMelanie Coverage experience of this tool used in monitoring Host Cell Protein (HCP) impurities in biopharmaceutical products.

Lab six FUJIFILM Diosynth Biotechnologies case study

Lab seven Introduction to ÄKTAflux S system; normal flow clarification of bovine serum albumin (BSA) and vitamin B12 from a yeast solutionDiscussion of semi-automated lab-scale filtration system, which, although designed for crossflow filtration, can also be utilised for normal flow filtration. Experiment to separate BSA from a yeast solution.

COURSE OVERVIEW

DAY 1: Introduction to downstream bioprocessingLecture one Introduction to chromatography and downstream processes

Lecture two The principles of protein purification, why proteins should be purified and the rationale for testing Host Cell Proteins (HCP)

Lecture three Hardware and software tools for downstream process development> The Cytiva AKTA platform and associated

hardware> An emphasis on UNICORN software for

the control of AKTA, the generation of methods, the evaluation of results and the administration of both hardware and data

> A brief introduction to advanced functions- multistep purification and UNICORN Design of Experiments

Lab one Chromatography> AKTA hardwar > The AKTA flowpath> Pumps, valves and monitors> Critical housekeeping> Sample pump and frac pumps

Lab two Column Packing> Resin slurries> Intro to HIScale> Pack a HiScale 16/20

Lab three Imaging> HCP and ELISA techniques

DAY 3: Membrane separations

Lab eight Concentration and diafiltration of clarified BSA and vitamin B12 using the ÄKTAflux S systemExperiment on a crossflow filtration process which has broad use in the biopharmaceutical industry: concentration and diafiltration of a protein solution. Analysis of results of experiments.

Lecture seven Operation of a crossflow filtration processDeeper dive into setting up and running a crossflow filtration process. Includes system design, filter choice, and critical operating parameters.

Lecture eight Hollow fibre filter installation and testing the clean water flux of a crossflow filterInstruction on use of a common crossflow filter type used in the biopharmaceutical industry: the hollow fibre. Clean water performance test, also called normalised water permeability, will be performed.